# CMDh just updated MRP/DCP submission requirements. What should applicants check before their next procedure?

> After its 13–14 October 2026 meeting, the CMDh updated the MRP/DCP validation advice, both compilations of national data requirements, the request form for an RMS in DCP, the MRP/RUP request form and the blue-box requirements. National requirements are now marked as validation or non-validation issues, a silent CMS can no longer hold a procedure indefinitely, and the RMS request form asks new questions about Article 10a, bioequivalence timing and ASMF numbers.

Canonical: https://rafihive.com/insights/cmdh-mrp-dcp-updates-october-2026  
Author: RafiHive Regulatory Team, RafiHive  
Category: Regulatory Operations  
Published: 2026-10-28  
Last reviewed: 2026-10-28

## What did the CMDh change in October 2026?

The CMDh, the coordination group for the mutual recognition and decentralised procedures, met on 13–14 October 2026 and published its report on 21 October. On 22 October it updated the documents that decide whether an MRP, DCP or repeat-use procedure can start. For applicants, the practical message is that validation is not only about the CTD: published national requirements, request forms and Module 1 details can still stop Day 0.

| Document | What changed |
| --- | --- |
| Procedural advice on validation of MR, repeat-use and DC procedures (CMDh/401/2019 Rev. 2) | The RMS can start the procedure, in exceptional cases, when a CMS does not react to validation responses within a set timeframe. |
| Data requested for new applications in the MRP/DCP (CMDh/043/2007 Rev. 22) | Each national requirement is now marked as a validation issue (prevents procedure start) or a non-validation issue (does not). Some requirements were deleted. |
| Data requested for variations and/or renewals in the MRP/DCP | Updated in the same way as the new-applications compilation. |
| Request form for RMS in DCP | Only correctly and fully completed forms are considered. New questions on Article 10a, equivalence study completion dates and ASMF numbers. |
| MRP/RUP request form | Updated CEP footnote on updating the dossier to the latest CEP before the procedure; more specific ERA requirements for Module 1.6. |
| 'Blue-box' requirements (CMDh/258/2012 Rev. 28) | New revision dated October 2026, one month after Rev. 27. The CMDh's report does not summarise what changed. |
| Article 5 recommendations | Deletion of a batch size of the finished product can be submitted as a type IA variation under Q.II.b.4.z, subject to conditions. |

## Can a silent CMS still block the start of a procedure?

Not indefinitely. Under the validation advice, a CMS that has declared an application invalid must tell the RMS whether it has become valid within 7 days of the missing information being supplied. The update adds what happens when it does not.

1. If no update arrives from the CMS within those 7 days, the RMS tells the CMS that the procedure will start unless the CMS confirms within 4 days that the invalidation issue is still unresolved.
2. If the CMS does not react within those 4 days, the application is automatically considered valid.
3. The RMS may then start the procedure.

The rest of the framework is unchanged. The validation period is 14 calendar days from receipt of a technically valid application by the RMS and all CMSs. The applicant should tell the RMS within 3 days when each CMS received the application. The RMS cannot backdate the start. CMDh describes the new route as an exceptional case, so it is a safeguard against a stalled procedure, not a new timetable to plan around.

For applicants, the practical consequence is evidence. The 7 days run from the date the missing information was supplied, so keep a dated record of every validation response sent to each CMS, copied to the RMS.

## Which national requirements can stop Day 0?

The CMDh compilations list data that some Member States request on top of EU legislation and the CTD. Member States not listed request no additional data. In the October 2026 revision of the new-applications compilation, every entry is marked as either a validation issue, which prevents the procedure from starting, or a non-validation issue, which does not. Previously, only some entries said so in their text.

Examples from the new-applications compilation (CMDh/043/2007 Rev. 22):

| Marked as | Examples |
| --- | --- |
| Validation issue: no procedure start | Cyprus: a pharmacovigilance and scientific services contact person resident in Cyprus, or a declaration that one will be appointed. Poland: register of entrepreneurs extract, proof that applicant and MAH are one entity, ASMF letter of access in original or with a qualified electronic signature. Italy: revenue stamps on the cover letter, and a true-copy declaration where Italy is RMS. Greece: signed cover letter and power of attorney. Bulgaria and Romania: notarised letter of authorisation. |
| Non-validation issue: procedure can start | A national pharmacovigilance responsible person in Belgium, Greece, Spain, France, Croatia and Portugal. The French 'exploitant'. The trademark in Greece. A local representative in Croatia. Belgium's declaration of conformity for national translations, now due in the national phase. |
| Deleted | The requirement for an application form signed by the MAH of the product in the RMS, and Bulgaria's entry for a national pharmacovigilance responsible person. |

Non-validation issues still have a deadline. Under the validation advice, missing or incorrect documents must be supplied by Day 10 in MRP and repeat-use procedures and by Day 30 in DCP. And a national request that is not in the published compilation is itself a non-validation issue: it cannot hold up the start.

This table is a selection, not a substitute for the compilation. Read the current version of both compilations for every Member State in the procedure before submission.

> Passing validation is not only about the CTD. A signature, a stamp or a local contact in one Member State can still stop Day 0 for all of them.

## What does the new RMS request form for DCP ask?

The common request form for an RMS in a decentralised procedure now states that only correctly and fully completed forms will be considered, and it asks three new things.

- For applications under Article 10a of Directive 2001/83/EC (well-established use): whether a suitable reference medicinal product for an application under Article 10 is available on the EU market and, if it is, why Article 10a was chosen.
- For bioequivalence or other equivalence studies: the date of completion, or the expected date if the study is not finished.
- For an active substance master file: the ASMF number.

Each question moves a decision earlier. The legal basis has to be justified when the RMS slot is requested, not at validation. An RMS can see whether the equivalence study will be finished by the requested start date. And the ASMF has to be identified when the slot is requested, which matters because a missing or outdated ASMF, or letter of access, is a validation issue.

## What changed in the MRP/RUP request form?

Two things. The footnote on CEPs, about submitting a variation to update the dossier with the latest CEP version before the MRP or repeat-use procedure, has been updated. And the requirements for the environmental risk assessment in Module 1.6 have been specified further.

Both are worth checking before the request is sent. An unjustified missing ERA is one of the conditions under which a Member State can invalidate the application. And a repeat-use procedure is built on the dossier as authorised in the RMS, so a CEP that has moved on since then needs a variation first.

## A pre-submission check for MRP and DCP applicants

Before requesting an RMS or starting the procedure, check in this order:

1. Legal basis and reference product: Article 10 or 10a, and the justification the RMS request form now asks for.
2. Equivalence studies: completion dates that support the requested start.
3. Active substance documentation: ASMF number, current ASMF version and a letter of access in the form each Member State requires; for a CEP, the latest version in the dossier.
4. Module 1.6: an environmental risk assessment, or a justified absence, to the current specification.
5. National requirements: every validation issue in the current compilation for every Member State in the procedure.
6. Non-validation items: a plan to deliver them by Day 10 (MRP/RUP) or Day 30 (DCP).
7. Labelling: the blue-box requirements in CMDh/258/2012 Rev. 28 for each Member State, compared with your mock-ups.

## Our view: the CMDh is making the validation rules visible

These are not headline changes, and they will not change anyone's regulatory strategy. They will change how many procedures start on time. Marking each national requirement as blocking or not tells applicants where to spend the last week before submission, and the new route past a silent CMS removes one of the few ways a procedure could stall without anyone deciding it should.

The applicants who benefit most are the ones entering several Member States for the first time, often from outside the EU. For them, validation risk sits less in the science than in national administrative detail: who signs, in what form, with which local contact. That detail is published. The work is in checking it against the current revision, for every country, every time.

## Where RafiHive fits

RafiHive's Module 1 gap check is a cited first-pass review of an EU regional Module 1 for qualified RA review. It helps find likely omissions, inconsistencies and validation risks before submission. It is not a competent-authority validator, and it does not decide whether a dossier is valid or complete. The packaging and labelling check quotes each selected market's entry from the blue-box requirements, now CMDh/258/2012 Rev. 28, and names that revision in every blue-box finding. For questions about the MRP and DCP rules themselves, RafiHive answers from official EU and CMDh sources and cites the passage it used, so the answer can be checked against the current revision.

## Official sources

- [CMDh: Report from the CMDh meeting held on 13–14 October 2026 (EMA/CMDh/225609/2026, 21 October 2026)](https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/CMDh_pressreleases/2026/CMDh_press_release_-_October_2026.pdf)
- [CMDh: Procedural advice on validation of MR/Repeat-use/DC procedures (CMDh/401/2019 Rev. 2, October 2026)](https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_401_2019_Rev2_2026_10_clean_-_Validation_of_MR_-_Repeat_use_-_DC_procedures.pdf)
- [CMDh: Data requested for new applications in the MRP/DCP (CMDh/043/2007 Rev. 22, October 2026)](https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_043_2007_Rev22_2026_10_clean_-_Data_requested_for_New_Applications.pdf)
- [CMDh: Procedural guidance on variations, including data requested for variations and/or renewals in the MRP/DCP](https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation.html)
- [CMDh: Templates for applications for MA, including the request form for RMS in DCP](https://www.hma.eu/human-medicines/cmdh/templates/applications-for-ma.html)
- [CMDh: MRP/RUP request form](https://www.hma.eu/human-medicines/cmdh/templates/rup.html)
- [CMDh: 'Blue-box' requirements (CMDh/258/2012 Rev. 28, October 2026)](https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_258_2012_Rev28_2026_10_clean_-_BlueBox_requirements.pdf)
- [CMDh: Article 5 recommendations on the classification of unforeseen variations](https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation/art-5-recommendations.html)
- [EUR-Lex: Directive 2001/83/EC, Articles 10 and 10a](https://eur-lex.europa.eu/eli/dir/2001/83/oj)

## Changes since first publication

- 2026-10-28: First published after the CMDh's report from its 13–14 October 2026 meeting (EMA/CMDh/225609/2026, 21 October 2026) and the documents it updated on 22 October 2026, including CMDh/401/2019 Rev. 2, CMDh/043/2007 Rev. 22 and CMDh/258/2012 Rev. 28.

This content supports research and preparation. Confirm current source versions and have a qualified regulatory professional review decisions before use.